The Food and Drug Administration late Friday approved the first-ever pill that can be taken at home for postpartum depression.
The medication, called zuranolone, and jointly developed by pharmaceutical companies Biogen Inc.
and Sage Therapeutics
is taken daily for two weeks, the FDA said in its release.
In a pair of clinical trials involving women who experienced severe depression after having a baby, the drug improved symptoms including anxiety, trouble sleeping, loss of pleasure, low energy, guilt or social withdrawal as soon as three days after the first pill.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
”And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” she said.
Women who are breastfeeding or had mild or moderate depression weren’t included in the trials.
Until now, the only available option for this condition has been an intravenous injection that the FDA approved in 2019. It requires patients to stay in a hospital for two-and-a-half days.
Postpartum depression affects one in eight new mothers in the U.S., according to the Centers for Disease Control and Prevention. Researchers suggest the actual rate may be higher and that half of such cases go undiagnosed.
Research finds that postpartum depression is more intense and lasts longer than the typical worries, sadness or tiredness that many women experience after giving birth. The condition can make it harder for mothers to bond with their babies and may increase the likelihood of developmental delays in infants.
Drug overdoses and suicides are leading causes of maternal death in the U.S., contributing to nearly one in four pregnancy-related deaths, according to the CDC.
Zuranolone stimulates a brain receptor called GABA that slows down the brain and helps control anxiety and stress. The drug, through trials, is thought to calm women suffering from postpartum depression enough to allow them to rest, which also improves symptoms.
Shares of Biogen are up 23% over the past year, and Sage has lost 14%, while the S&P 500
is up 8% over the same time.